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Use of Thiram

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Use of Thiram United States Prevention, Pesticides EPA 738-R-04-012 Environmental Protection and Toxic Substances September 2004 Agency (7508C) Reregistration Eligibility Decision for Thiram UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY WASHINGTON, D.C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES CERTIFIED MAIL Dear Registrant: This is to inform you that the Environmental Protection Agency (hereafter referred to as EPA or the Agency) has completed its review of the available data and public comments received related to the preliminary risk assessments for the fungicide thiram. The enclosed Reregistration Eligibility Decision (RED) document was approved on September 30, 2004. Public comments and additional data received were considered in this decision. Based on its review, EPA has identified risk mitigation measures that the Agency believes are necessary to address the environmental risks associated with the current use of thiram. EPA is now publishing its Reregistration Eligibility Decision (RED) and risk management decision for thiram and its associated human health and environmental risks. The RED and supporting risk assessments for thiram are available to the public in EPA’s Pesticide Docket OPP-2004-0183 at: www.epa.gov.edockets. In addition, the Thiram RED may be downloaded or viewed at: www.epa.gov/pesticides/reregistration/status.htm. Earlier information on thiram, including public comments, can be found under docket OPP-2003-0287. The Thiram RED was developed through EPA’s public participation process, published in the Federal Register on May 14, 2004, which provides opportunities for public involvement in the Agency’s pesticide tolerance reassessment and reregistration programs. Developed in partnership with USDA and with input from EPA’s advisory committees and others, the public participation process encourages robust public involvement starting early and continuing throughout the pesticide risk assessment and risk mitigation decision making process. The public participation process encompasses full, modified, and streamlined versions that enable the Agency to tailor the level of review to the level of refinement of the risk assessments, as well as to the amount of use, risk, public concern, and complexity associated with each pesticide. Using the public participation process, EPA is attaining its strong commitment to both involve the public and meet statutory deadlines. Please note that the thiram risk assessment and the attached RED document concern only this particular pesticide. This RED presents the Agency’s conclusions on the dietary, drinking water, occupational and ecological risks posed by exposure to thiram alone. This document also contains both generic and product-specific data that the Agency intends to require in Data Call-Ins (DCIs). Note that DCIs, with all pertinent instructions, will be sent to registrants at a later date. Additionally, for product- specific DCIs, the first set of required responses will be due 90 days from the receipt of the DCI letter. The second set of required responses will be due eight months from the receipt of the DCI letter. As part of the RED, the Agency has determined that thiram will be eligible for reregistration provided that all the conditions identified in this document are satisfied, including implementation of the risk mitigation measures outlined in Section IV of the document. Sections IV and V of this RED document describe labeling amendments for end-use products and data requirements necessary to implement these mitigation measures. Instructions for registrants on submitting the revised labeling can be found in the set of instructions for product-specific data that accompanies this document. Should a registrant fail to implement any of the risk mitigation measures outlined in this document, the Agency will continue to have concerns about the risks posed by thiram. Where the Agency has identified any unreasonable adverse effect to human health and the environment, the Agency may at any time initiate appropriate regulatory action to address this concern. At that time, any affected person(s) may challenge the Agency’s action. If you have questions on this document or the label changes necessary for reregistration, please contact the Chemical Review Manager, Craig Doty, at (703) 308-0112. For questions about product reregistration and/or the Product DCI that accompanies this document, please contact Venus Eagle at (703) 308-8045. Sincerely, Debra Edwards, Ph.D. Director, Special Review and Reregistration Division Attachment REREGISTRATION ELIGIBILITY DECISION for Thiram List A CASE 0122 TABLE OF CONTENTS Thiram TEAM ................................................................. i EXECUTIVE SUMMARY .......................................................v I. Introduction ...............................................................1 II. Chemical Overview ........................................................2 A. Regulatory History ....................................................2 B. Chemical Identification .................................................2 C. Use Profile ...........................................................3 D. Estimated Usage of Thiram .............................................5 III. Summary of Thiram Risk Assessment .........................................6 A. Human Health Risk Assessment .........................................6 1. Dietary Risk from Food .............................................6 a. Toxicity and Carcinogenicity ...................................6 b. FQPA Safety Factor ..........................................7 c. Population Adjusted Dose (PAD) & Reference Dose (RfD) ..........8 d. Exposure Assumptions .......................................10 e. Acute Dietary (Food) Risk ....................................11 f. Chronic Dietary (Food) Risk ..................................12 g. Cancer Dietary Risk Assessment .............................. 12 2. Dietary Risk from Drinking Water ................................... 12 a. Surface Water .............................................. 13 b. Ground Water .............................................. 13 3. Residential Risk .................................................. 14 a. Aggregate Risk ............................................. 15 4. Occupational Risk ................................................. 15 a. Toxicity ................................................... 16 b. Occupational Risk Assessment ................................ 16 c. Incident Reports ............................................ 20 B. Environmental Risk Assessment ........................................ 20 1. Environmental Fate and Transport ................................... 20 2. Ecological Effects (Toxicity) Assessment .............................. 21 3. Ecological Risk Calculations ........................................ 23 4. Ecological Risk Profile ............................................. 24 a. Risk to Birds ............................................... 24 b. Risk to Mammals ........................................... 26 c. Risk to Aquatic Animals ...................................... 27 d. Risk to Aquatic Plants ....................................... 29 e. Risk to Endangered Species ................................... 30 IV. Risk Management, Reregistration, and Tolerance Reassessment Decision .......... 35 A. Determination of Reregistration Eligibility ................................ 35 B. Public Comments and Responses ........................................ 35 C. Regulatory Position ................................................... 35 1. Food Quality Protection Act Findings ................................. 35 a. Determination of Safety to U.S. Population ....................... 36 b. Determination of Safety to Infants and Children .................. 36 c. Endocrine Disruptor Effects ................................... 38 d. Cumulative Risks ........................................... 38 2. Tolerance Summary ............................................... 38 a. Tolerances Currently Listed Under 40 CFR §180.301 .............. 38 b. Codex Harmonization ........................................ 39 D. Regulatory Rationale ................................................. 39 1. Human Health Risk Management .................................... 40 a. Dietary (Food) Risk Mitigation ................................ 40 b. Drinking Water Risk Mitigation ............................... 40 c. Residential Risk Mitigation ................................... 40 d. Occupational Risk Mitigation ................................. 44 2. Environmental Risk Mitigation ...................................... 45 3. Other Labeling Requirements ....................................... 44 4. Endangered Species Considerations .................................. 45 a. The Endangered Species Program .............................. 45 b. General Risk Mitigation ...................................... 45 c. Species-Specific Risk Mitigation ............................... 45 d. Endangered Species Determination ............................. 46 V. What Registrants Need to Do ............................................... 47 A. Manufacturing Use Products ........................................... 48 1. Additional Generic Data Requirements ................................ 48 2. Labeling for Technical and Manufacturing-Use Products ................. 49 B. End-Use Products .................................................... 50 1. Additional Product-Specific Data Requirements ........................
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